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Evaluating the Health Benefits of Workplace Policies and Practices - Phase II (WFHS)

13 de dezembro de 2017 atualizado por: Lisa Berkman, Harvard School of Public Health (HSPH)
Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically, few have been studied using scientifically sound designs. To address this, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies. For Phase 2, the WFHN implemented an innovative intervention based on Phase I pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. Customized interventions were performed separately in workplaces of two separate corporate partners.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Although the prevalence of "family-friendly" policies in US workplaces has increased dramatically in recent years, few have been studied using scientifically sound designs. To address this critical gap, the NIH and CDC formed the Work, Family, and Health Network (WFHN). During Phase 1, the WFHN designed and conducted multiple pilot and feasibility studies.

For Phase 2, the WFHN implemented an innovative intervention based on Phase 1 pilot studies that is designed to increase family-supportive supervisor behaviors and employee control over work, and to evaluate the intervention using a group randomized experimental design. The goal of the study is to assess the effects of a workplace intervention designed to reduce work-family conflict, and thereby improve the health and well being of employees. The study intervention is grounded in theory from multiple disciplines and supported by findings from pilot/feasibility studies. The study seeks to inform the implementation of evidence-based, family-friendly policies, and thereby improving the health and well-being of employees and their families nationwide.

The investigators assess the efficacy of the intervention via two independent, group-randomized field experiments, one at each of two employers representing different industries, referred to by alias as "LEEF" and "TOMO". LEEF is an extended care (nursing home) company and facilities were excluded if they were in very isolated settings, if there were fewer than 30 direct patient-care employees, or if facilities were recently acquired. TOMO is an Information Technology company. Within each industry partner, worksites of 50-120 employees each were randomly assigned to intervention or usual practice conditions. All employee and supervisor participants were assessed at baseline and at 6-, 12-, and 18-months post baseline, including survey interviews and health assessments.

Primary health outcomes were comprised of a cardiometabolic risk score using selected biomarkers and sleep duration and quality objectively measured using wrist actigraphy. These primary health outcomes were independently assessed as change from baseline to the 12-month wave, and separately in the two industries.

Tipo de estudo

Intervencional

Inscrição (Real)

2753

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Massachusetts
      • Cambridge, Massachusetts, Estados Unidos, 02318
        • Harvard School of Public Health

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • LEEF: employees and supervisors with at least 22 weekly hours of direct patient care work in selected facilities
  • TOMO: employees and supervisors located in the two data collection cities

Exclusion Criteria:

  • LEEF: nightwork schedule
  • TOMO: independent contractor classification

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: LEEF Industry only: Intervention
Customized to the "Leef" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors.
The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
Sem intervenção: LEEF Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace
Experimental: TOMO Industry only: Intervention
Customized to the "Tomo" (alias) workplace: A 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors.
The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
Sem intervenção: TOMO Industry only: Usual Practice
Continued work conditions and practice as "Usual Practice" in that workplace

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in total sleep time
Prazo: baseline to one year later
Average 24 hour total sleep time as assessed by ~1 week of actigraphy
baseline to one year later
change in wake after sleep onset
Prazo: baseline to one year later
Amount of nightime wake after sleep onset as assessed by ~1 week of actigraphy
baseline to one year later
change in cardiometabolic risk score
Prazo: baseline to one year later
The cardiometabolic risk score was created based on modifiable risk factors using an independently validated CVD risk score developed from the Framingham offspring study; including BMI, blood pressure, HbA1C, cholesterol, and tobacco consumption.
baseline to one year later

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
change in sleep insufficiency
Prazo: baseline to one year later

Sleep insufficiency was assessed by the following question: How often during the past 4 weeks did you get enough sleep to feel rested upon waking up? Would you say never, rarely, sometimes, often, or very often?

YES - NEVER/RARELY

NO - SOMETIMES OFTEN VERY OFTEN

baseline to one year later
change in insomnia symptoms
Prazo: baseline to one year later

Insomnia symptoms were assessed by the following question: During the past 4 weeks, how often did you wake up in the middle of the night or early morning? (Would you say never, less than once a week, once or twice a week, or three or more times a week?)

YES - THREE OR MORE TIMES A WEEK

NO - NEVER/LESS THAN ONCE A WEEK/ONCE OR TWICE A WEEK

baseline to one year later

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Lisa F Berkman, PhD, Harvard School of Public Health (HSPH)
  • Investigador principal: Orfeu M Buxton, PhD, Brigham and Women's Hospital; Harvard Medical School; Harvard School of Public Health; Pennsylvania State University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2009

Conclusão Primária (Real)

1 de dezembro de 2012

Conclusão do estudo (Real)

1 de dezembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

28 de janeiro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de janeiro de 2014

Primeira postagem (Estimativa)

30 de janeiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de dezembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de dezembro de 2017

Última verificação

1 de dezembro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • P16633
  • U01AG027669 (Concessão/Contrato do NIH dos EUA)
  • U01HD051218 (Concessão/Contrato do NIH dos EUA)
  • U01HD051256 (Concessão/Contrato do NIH dos EUA)
  • U01HD051276 (Concessão/Contrato do NIH dos EUA)
  • U01HD051217 (Concessão/Contrato do NIH dos EUA)
  • R01HL107240 (Concessão/Contrato do NIH dos EUA)
  • U01OH008788 (Concessão/Contrato do NIH dos EUA)
  • U01HD059773 (Concessão/Contrato do NIH dos EUA)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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